Perceptions of Vaping Products

Ohio State University Comprehensive Cancer Center53 enrolled

Overview

This clinical trial studies the effects, appeal, and abuse liability of 6-methyl nicotine (metatine) electronic cigarettes among young adults.

PRIMARY OBJECTIVES: I. Assess the pharmacokinetics of metatine and nicotine electronic (e)-cigarettes. II. Assess the abuse liability and appeal of commercial e-cigarettes containing metatine versus nicotine. III. Determine the impact of metatine on e-cigarette puffing behavior (topography). OUTLINE: Participants attend 3 sessions where they will be randomized to 1 of 3 types of e-cigarette. Participants will use the e-cigarette ad-libitum for 30 minutes and answer survey questions about their perceptions of the e-cigarette. Participants must also undergo 4 blood draws during the vaping session.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Abuse Tobacco Exposure

Interventions

Biospecimen CollectionOTHER

Undergo blood sample collection

Survey AdministrationOTHER

Complete Surveys

Vaping TopographyBEHAVIORAL

Use e-cigarette connected to a topography device

Eligibility

Sex: ALLMin age: 21 YearsMax age: 34 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 21-34 years * Current nicotine EC user (defined as ≥ weekly use over the past 3 months) * Willing to provide informed consent and abstain from using any e-cigarette at least 12 hours prior to the three lab sessions * Read and speak English Exclusion Criteria: * Recently coronavirus disease 2019 (COVID-19) positive (defined as a positive test in the past 30 days) or a recent COVID-19 hospitalization (defined as a hospitalization within the past 6 months) * Unstable or significant psychiatric conditions (past and stable conditions will be allowed) * History of cardiac event or distress within the past 3 months * Have suffered from any serious lung disease or infection (e.g., tuberculosis, cystic fibrosis, or lung cancer) in the past 30 days * Are currently pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test) * Have hemophilia or another type of bleeding disorder * Are blind, severely visually impaired, deaf, hard of hearing, or have a severe motor disability

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Pharmacokinetics of metatine and nicotine e-cigarettes

Pharmacokinetics of metatine and nicotine e-cigarettes will be examined by measuring the concentration of metatine and nicotine in blood plasma at different timepoints throughout the study vaping session.

Time frame: Pre-vaping session, Minute 5 of vaping session, Minute 15 of vaping session, Minute 30 of vaping session

E-cigarette puffing behavior

E-cigarette puffing behavior will be measured with a topography device that records frequency, duration, and flow rate of e-cigarette puffs. These measures are combined to inform the overall measure of e-cigarette puffing behavior.

Time frame: Week 1, Week 2, Week 3

Sensory perceptions of EC vaping experience

Sensory perceptions of vaping will be measured by the Sensory E-cigarette Expectancies Scale (SEES) questionnaire. The SEES asks questions about sensory experiences associated with vaping on a scale from 0 (Never) - 4 (Almost Always).

Time frame: Minute 5 of vaping session, Minute 30 of vaping session

Appeal ratings

Participants will rate appeal (e.g., liking, disliking) on Visual Analogue Scales (range, 0-100).

Time frame: Minute 5 of vaping session, Minute 30 of vaping session

Sensory ratings

Participants will rate sensory attributes (e.g., harshness, coolness) on Visual Analogue Scales (range, 0-100).

Time frame: Minute 5 of vaping session, Minute 30 of vaping session

Relief of withdrawal symptoms

Nicotine withdrawal relief will be measured by the Minnesota Nicotine Withdraw Scale (MNWS). The MNWS asks users how much they are currently feeling certain nicotine withdraw symptoms on a scale of None, Slight, Moderate, Mild, or Severe.

Time frame: Pre-vaping session, Minute 5 of Vaping Session, Minute 30 of vaping session

Data from ClinicalTrials.gov

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